Halaven(甲磺酸艾日布林)新型化疗药获准用于治疗晚期乳腺癌

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Halaven(eribulin mesylate)注射剂 – 以前名E7389

美国食品和药品监督管理局 2010年11月15日批准Halaven(eribulin mesylate)治疗转移乳癌患者对其晚期疾病曾接受至少2种既往化疗方案。

根据美国国家癌症研究所，乳癌是妇女中第二位领先的癌死亡相关原因。本年度，估计207,090妇女将被诊断有乳癌，而39,840妇女将死于该疾病。

Halaven是来自海海绵Halichondria okadai化疗活性化合物的一种合成形式。这种可注射的治疗是一种微管抑制剂，被认为通过抑制癌细胞生长起作用。接受Halaven前，患者应曾对早期或晚期乳癌接受既往基于蒽环类[anthracycline]-和紫杉烷类[taxane]-化疗。

在一项762例转移乳癌妇女对晚期疾病曾接受至少2种既往化疗方案的单独研究中确定Halaven的安全性和有效性。患者被随机赋予接受治疗用或者Halaven或被他们的肿瘤学家选择的不同的一种单药治疗。
研究被设计成测量当这种治疗开始直至患者死亡时间的长度(总生存)。接受Halaven患者中位总生存是13.1个月，与之比较接受某种单药治疗为10.6个月。
FDA的药物评价和研究中心所属肿瘤药我产品室主任Richard Pazdur, M.D.,说：“对早已接受其它治疗有侵袭型晚期乳癌妇女，治疗选择很有限。”“Halaven显示明确的生存效益和对妇女是一种重要的新选择。”

用Halaven治疗妇女报道的最常见副作用包括感染斗争中白细胞减少(中性粒细胞减少)，贫血，白血细胞数减少(白细胞减少症)，毛发脱落(脱发)，疲劳，恶心，软弱(虚弱), 神经损伤(周围神经病变)，和便秘。

FDA-批准用于治疗晚期，难治性乳癌的其它治疗包括Xeloda(卡培他滨[capecitabine])对紫杉醇[paclitaxel]和蒽环类-含化疗耐药乳癌患者；Ixempra(伊沙匹隆[ixabepilone])对蒽环类，紫杉烷类和Xeloda失败后晚期疾病患者；和Ixempra加Xeloda对基于蒽环类-和紫杉烷类化疗失败后晚期疾病患者。.

FDA Approves Eisai\'s Halaven™ (Eribulin Mesylate) Injection For Treatment Of Metastatic Breast Cancer

Eisai Inc. announced that the United States Food and Drug Administration (FDA) has approved Halaven™ (eribulin mesylate) Injection for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included two common chemotherapy treatments, an anthracycline and a taxane, for early or advanced breast cancer. Discovered and developed by Eisai, Halaven is a non-taxane, microtubule dynamics inhibitor that is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai.

\"Many women with metastatic breast cancer see their disease progress after receiving multiple therapies,\" said Linda Vahdat, M.D., Professor of Medicine, Division of Hematology & Medical Oncology at the Iris Cantor Women\'s Health Center at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City. \"Now, with the approval of Halaven, we can offer a new option that has been shown to improve survival in women with metastatic disease.\"

The FDA approval of Halaven is based on results from the pivotal Phase III clinical study EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician\'s Choice Versus Eribulin), which showed that patients treated with Halaven survived a median of 2.5 months longer than patients who received a single-agent therapy chosen by their physician (Treatment of Physician\'s Choice). Overall survival was 13.12 months with Halaven versus 10.65 months with TPC (p=0.041). In an updated survival analysis, conducted when 77 percent of events had been observed, the result was consistent with the primary analysis.

The most common side effects (incidence ≥ 25 percent) reported by patients receiving Halaven were neutropenia (low white blood cells), anemia (low red blood cells), asthenia/fatigue (weakness/tiredness), alopecia (hair loss), peripheral neuropathy (numbness, tingling or burning in the hands and feet), nausea and constipation. The most common serious side effects reported in patients receiving Halaven were neutropenia with or without fever (four percent and two percent, respectively). Severe weakness/tiredness occurred in 10 percent of patients receiving Halaven. The most common side effect resulting in discontinuation of treatment with Halaven was peripheral neuropathy (five percent).

\"The FDA approval of Halaven is significant news for the metastatic breast cancer community in an area of unmet medical need,\" said Lonnel Coats, President & CEO, Eisai Inc.

\"This achievement is consistent with our human health care mission of striving to produce therapies that may help make a difference in the lives of patients and their families.\"

About the Global Phase III Clinical Study (EMBRACE)

EMBRACE was an open-label, randomized, global, multi-center study designed to compare overall survival in patients treated with Halaven versus a Treatment of Physician\'s Choice (TPC arm). TPC was defined as any single-agent chemotherapy, hormonal treatment or biologic therapy approved for the treatment of cancer; or palliative treatment or radiotherapy administered according to local practice. The study included 762 patients with metastatic breast cancer who previously had been treated with an average of four prior chemotherapies. The vast majority of patients in the TPC arm received chemotherapy.

\"This approval is encouraging news for women with metastatic breast cancer,\" said Liz Thompson, president of Susan G. Komen for the Cure, the global leader in breast cancer advocacy. \"This is a challenging disease and the possibility of improved survival is meaningful to patients and their families.\"

Halaven is expected to be available in the United States within 10 business days after approval. In addition, Eisai has submitted regulatory applications for approval of eribulin mesylate for the treatment of metastatic breast cancer to regulatory agencies in Japan, the European Union, Switzerland and Singapore.

Important Safety Information about Halaven

Decreased White Blood Cells (Neutropenia)

A doctor will do a blood test to monitor patients\' complete blood cells before they receive each dose of HALAVEN, and will monitor patients more often if they develop lower white blood cells. If patients have severe neutropenia lasting longer than seven days or neutropenia with a fever, their next dose of HALAVEN will be delayed and reduced. Severe neutropenia occurred in 57 percent (287/503) of patients who received HALAVEN and lasted more than one week in 12 percent (62/503) of patients. Neutropenia with a fever occurred in five percent (23/503) of patients; two patients died from complications of neutropenia with a fever. Neutropenia with a fever can result in serious infections that could lead to hospitalization or death. Patients should call their healthcare provider immediately if they have any of the following symptoms; fever (100.5 º F), chills, coughing, and burning and pain when they urinate.

Nerve Disorders (Peripheral Neuropathy)

HALAVEN can cause numbness, tingling or burning in the hands and feet (peripheral neuropathy). Patients should be monitored closely for signs of neuropathy. If patients develop severe neuropathy, treatment with HALAVEN should be delayed until the neuropathy improves and the next dose of HALAVEN should be reduced. Severe peripheral neuropathy occurred in eight percent (42/503) of patients who received HALAVEN. Neuropathy lasting more than one year occurred in five percent of patients. Twenty-two percent (109/503) of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days. Peripheral neuropathy was the most common side effect that caused patients to stop taking HALAVEN.

Pregnancy and Nursing

HALAVEN may harm an unborn baby. Patients should avoid becoming pregnant while receiving HALAVEN. Patients should tell their healthcare providers right away if they become pregnant or think they may be pregnant while receiving HALAVEN. With their healthcare providers, patients should decide if they will take HALAVEN or breastfeed. They should not do both.

Heartbeat Changes

HALAVEN can cause changes in a patient\'s heartbeat (called QTc prolongation). This can cause irregular heartbeats that may lead to death. Healthcare providers will decide if patients need heart monitoring (electrocardiogram, or ECG) or blood tests during treatment with HALAVEN to watch for this problem.

Liver and Kidney Problems

A lower dose of HALAVEN should be used if patients have liver and/or kidney problems.

About Metastatic Breast Cancer

Metastatic breast cancer is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body.

In 2010, an estimated 207,000 women will be diagnosed with breast cancer in the United States and 40,000 women will die from the disease. Although statistics on metastatic breast cancer vary, approximately 10 percent of women with breast cancer will have metastatic disease at the time of diagnosis, and an estimated 20 percent of patients with early-stage disease will go on to develop metastatic disease within the next five years. An estimated one in four women with metastatic breast cancer is expected to survive five years.

About Halaven (eribulin mesylate) Injection

Halaven is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane either in the adjuvant or metastatic setting. A non-taxane, microtubule dynamics inhibitor, Halaven is derived from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into nonproductive aggregates.
Source:
Eisai Oncology
Eisai Inc.
Eisai Co., Ltd.

Halaven(甲磺酸艾日布林)新型化疗药获准用于晚期乳腺癌
2010年11月15日，美国食品药品管理局(FDA)宣布，Halaven(甲磺酸艾日布林)已获准用于治疗曾接受至少2种以前的晚期化疗方案治疗的转移性乳腺癌患者。

Halaven是一种从黑色软海绵(Halichondria okadai)中提取的一种有化疗活性化合物的合成制剂。该注射药是一种微管抑制剂，能抑制癌细胞生长。在接受Halaven治疗之前，患者应先接受以前的以蒽环类为基础和以紫杉烷为基础的化疗方案治疗早期或晚期乳腺癌。

Halaven的安全性与疗效在一项涉及762例转移性乳腺癌女性患者的单项研究中得到证实，这些患者曾采用至少2种以前的化疗方案治疗晚期疾病，她们被随机分配至接受Halaven治疗组或接受由其肿瘤医生选择的不同种单药治疗组。

该研究旨在测定总生存时间。Halaven治疗组的中位总生存时间为13.1个月，而单药治疗组为10.6个月。使用Halaven最常见的不良反应包括中性粒细胞减少症、贫血、白细胞减少症、脱发、疲乏、恶心、无力、便秘和周围神经病变。
HALAVEN（eribulin甲磺酸）由Eisai 1mg/2mL注射

Halaven approved for late-stage breast cancer

The FDA has approved Halaven (eribulin mesylate, from Eisai) for the treatment of patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease. This approval was based on a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. The study measured the length of time from when treatment was started until a patient\'s death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.
美国食品药物管理局已批准Halaven（eribulin甲磺酸，从卫材）为转移性乳腺癌患者谁已经收到了晚期疾病的至少两个前化疗方案治疗。这个批准是基于对762转移性乳腺癌的妇女谁收到了晚期疾病的至少两个疗程化疗前单一的研究。本研究测量的时间从一个时治疗，直到病人死亡（整体存活率）开始的长度。中位数接受Halaven患者的总生存期为13.1个月比10.6对于那些谁收到了单药治疗个月。

Halaven是从海海绵Halichondria okadai派生的chemotherapeutically活性化合物合成形式。这种注射疗法是一种微管抑制剂，相信通过抑制癌细胞的生长。接受Halaven之前，患者应接受早期或晚期乳腺癌前蒽环类和紫杉类为基础的化疗。